Dataset Information

Outcomes for Low-Risk Surgical Aortic Valve Replacement: A Benchmark for Aortic Valve Technology.

ABSTRACT: BACKGROUND:Two large, randomized trials are underway evaluating transcatheter aortic valve replacement (AVR) against conventional surgical AVR. We analyzed contemporary, real-world outcomes of surgical AVR in low-risk patients to provide a practical benchmark of outcomes and cost for evaluating current and future transapical AVR technology. METHODS:From 2010 to 2015, 2,505 isolated AVR operations were performed for severe aortic stenosis at 18 statewide cardiac institutions. Of these, 2,138 patients had a Society of Thoracic Surgeons predicted risk of mortality of less than 4%, and 1,119 met other clinical and hemodynamic criteria as outlined in the PARTNER 3 (The Placement of Transcatheter Aortic Valves) protocol. Patients with endocarditis, end-stage renal disease, ejection fraction of less than 0.45, bicuspid valves, and previous valve replacements were excluded. Outcomes of interest included operative death and postoperative adverse events. RESULTS:The median Society of Thoracic Surgeons predicted risk of mortality for the study-eligible patients was 1.44%, with a median age of 72 years (interquartile range [IQR], 65 to 78 years). Operative mortality was 1.3%, permanent stroke was 1.3%, and pacemaker requirement was 4.2%. The most common adverse events were transfusion of 2 or more units of red blood cells (18%) and atrial fibrillation (28%). The median length of stay was 6 days (IQR, 5 to 8 days). Median total hospital cost was $37,999 (IQR, $30,671 to $46,138). Examination of complications by age younger than 65 vs 65 or older demonstrated a significantly lower need for transfusion (11.2%, p < 0.001) and incidence of atrial fibrillation (17.1%, p < 0.001) but no difference in operative mortality (2.2% vs 0.9%, p = 0.1), major morbidity (10.4% vs 12.6%, p = 0.3), or total hospital costs. CONCLUSIONS:Low-risk patients undergoing surgical AVR in the current era have excellent results. The most common complications were atrial fibrillation and bleeding. These real-world results should provide additional context for upcoming transcatheter clinical trial data.

SUBMITTER: Johnston LE

PROVIDER: S-EPMC5610058 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Outcomes for Low-Risk Surgical Aortic Valve Replacement: A Benchmark for Aortic Valve Technology.

Johnston Lily E LE Downs Emily A EA Hawkins Robert B RB Quader Mohammed A MA Speir Alan M AM Rich Jeffrey B JB Ghanta Ravi K RK Yarboro Leora T LT Ailawadi Gorav G

The Annals of thoracic surgery 20170611 4

<h4>Background</h4>Two large, randomized trials are underway evaluating transcatheter aortic valve replacement (AVR) against conventional surgical AVR. We analyzed contemporary, real-world outcomes of surgical AVR in low-risk patients to provide a practical benchmark of outcomes and cost for evaluating current and future transapical AVR technology.<h4>Methods</h4>From 2010 to 2015, 2,505 isolated AVR operations were performed for severe aortic stenosis at 18 statewide cardiac institutions. Of th ...[more]

PMID: 28610884

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Project description:ImportanceTranscatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce.ObjectiveTo compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS.Design, setting, and participantsThis retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts.ExposuresPrimary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization.Main outcomes and measuresThe primary outcomes were 30-day and 3-year survival.ResultsOverall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not.Conclusions and relevanceTranscatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.

Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.

Dataset Information

Outcomes for Low-Risk Surgical Aortic Valve Replacement: A Benchmark for Aortic Valve Technology.

Publications

Outcomes for Low-Risk Surgical Aortic Valve Replacement: A Benchmark for Aortic Valve Technology.

Similar Datasets

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